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Pulmonary And Renal Support During Acute Respiratory Distress Syndrome (PARSA)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01239966
First Posted: November 15, 2010
Last Update Posted: February 23, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jerome Allardet-Servent, MD, Hôpital Européen Marseille
  Purpose

In patients presenting with the acute respiratory distress syndrome (ARDS), mechanical ventilation with low tidal volume (6 ml/kg predicted body weight) is the current gold standard for supportive care. However, despite a relative low tidal volume, approximatively one third of patients will experienced tidal hyperinflation, a phenomenon known to induce pulmonary and systemic inflammatory response. A further reduction of the tidal volume to 4 ml/kg (PBW) will prevent pulmonary area from tidal hyperinflation. As a result, hypercarbia and respiratory acidosis are commonly observed with such very low tidal ventilation. Extra corporeal CO2 removal is one of a mean to normalize arterial CO2 tension.

Patients with ARDS also frequently develop acute renal failure which may required Renal Replacement Therapy. Some data suggests that starting early the RRT may favor outcome.

The investigators hypothesized that a strategy combining ECCOR and RRT early in the course of patients presenting ARDS and acute renal failure will allow the tidal volume to be further reduced, providing lung protection, while avoiding the arterial CO2 tension to be increased.

For this purpose, the investigators sought to evaluate the safety and efficacy of adding a membranel oxygenator within an hemofiltration circuit, either upstream or downstream of the hemofilter.


Condition Intervention Phase
Acute Respiratory Distress Syndrome Acute Renal Failure Device: Combined ECCOR and RRT Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Safety and Efficacy of Combined Extracorporeal CO2 Removal and Renal Replacement Therapy in Patients With the Acute Respiratory Distress Syndrome and Acute Renal Failure

Resource links provided by NLM:


Further study details as provided by Jerome Allardet-Servent, MD, Hôpital Européen Marseille:

Primary Outcome Measures:
  • Arterial carbon dioxide reduction [ Time Frame: 20 min ]
    20 % reduction of arterial carbon dioxide tension after 20 min of combined ECCOR and RRT


Secondary Outcome Measures:
  • Gas transfer measurement [ Time Frame: 20 min, H1, H6, H12, H24, H36, H48 and H72. ]
    Measurement of PO2 and PCO2 before and after the membrane oxygenation

  • Arterial blood gases [ Time Frame: 20 min, H1, H6, H12, H24, H36, H48 and H72. ]
    Measurement of arterial blood gases

  • carbon dioxide elimination (VCO2) [ Time Frame: 20 min, H1, H6, H12, H24, H36, H48 and H72. ]
    Measurement of carbon dioxide elimination rate at the ventilator and at the membrane oxygenator

  • Respiratory mechanics and hemodynamic parameters [ Time Frame: 20 min, H1, H6, H12, H24, H36, H48 and H72. ]
    Measurement of respiratory mechanics and hemodynamic parameters

  • Safety monitoring [ Time Frame: 20 min, H1, H6, H12, H24, H36, H48 and H72. ]

    Continuous measurement of the differential pressure across the oxygenator membrane and across the hemofilter.

    Assessment of catheter dysfunction, clotting or disruption of the extra-corporeal circuit, clotting of the oxygenator membrane or of the hemofilter.

    Assessment of patient's haemorragic or thrombotic complications.



Enrollment: 11
Study Start Date: November 2010
Study Completion Date: June 2015
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Combined ECCOR and RRT
    Insertion of a membrane oxygenator (Hilite 2400 LT, Medos, Germany) within an hemofilter circuit (M150,PrismaFlex, Hospal); either upstream or downstream of the hemofilter.
  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Acute Respiratory Distress Syndrome according to the AECC definition
  • Acute Renal Failure according to the RIFLE definition

Exclusion Criteria:

  • Age < 18 years
  • PaO2/FiO2 < 100 with FIO2 = 1 and PEEP > 18 cmH2O
  • DNR order or death expected within the next 3 days
  • Intracranial haemorrhage or hypertension
  • Heparin allergy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01239966


Locations
France
Hopital Paul Desbief
Marseille, France, 13002
Hopital Ambroise Pare
Marseille, France, 13006
Sponsors and Collaborators
Hôpital Européen Marseille
Investigators
Principal Investigator: Jérôme Allardet-Servent, MD Hopital Ambroise Pare
  More Information

Additional Information:
Publications:
Responsible Party: Jerome Allardet-Servent, MD, MD, MSc, Hôpital Européen Marseille
ClinicalTrials.gov Identifier: NCT01239966     History of Changes
Other Study ID Numbers: 2010-A00397-32
First Submitted: November 12, 2010
First Posted: November 15, 2010
Last Update Posted: February 23, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Jerome Allardet-Servent, MD, Hôpital Européen Marseille:
Acute Respiratory Distress syndrome
Acute renal Failure

Additional relevant MeSH terms:
Syndrome
Renal Insufficiency
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Acute Kidney Injury
Disease
Pathologic Processes
Kidney Diseases
Urologic Diseases
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury